Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System (SpyGlass)

Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry

Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities.

The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.

Study Overview

• Status: Withdrawn
• Conditions: Common Bile Duct Stones; Bile Duct Strictures
• Intervention / Treatment: Procedure: ERCP with cholangioscopy

Detailed Description

All patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium. The PI or study coordinator will meet with the patient and discuss the study, its objectives, and obligations with each patient. After full disclosure, informed consent will be obtained.

Upon consent, basic demographics and data from prior procedures (when available) will be recorded. An endoscopist proficient in ERCP, with expertise in cholangioscopy, will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps (SpyBiteTM) and other accessories as necessary. Procedure time, visual findings, number of biopsies taken, pathology, stone location, stone size, and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database. All patients will be followed for 6-12 months or surgery (stricture cohort) to assess accuracy or stone recurrence rates.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80202
      • University of Colorado, Denver
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Formation of a multi-site prospective database of all patients referred for the evaluation of indeterminate strictures or removal of difficult stones.

Description

Inclusion Criteria:

• All patients referred for the evaluation of indeterminate strictures or removal of difficult stones.

Exclusion Criteria:

• All patients who are unable or unwilling to give consent will not be included in this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bile duct Stricture; Patients referred for the evaluation of indeterminate strictures.	Procedure: ERCP with cholangioscopy
Common bile duct Stones; Patients referred for the removal of difficult stones.	Procedure: ERCP with cholangioscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone clearance rate	% of complete removal of bile duct stones	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy for indeterminate bile duct strictures	Correlation of pathology with surgical specimen or 6month f/u	6 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Colorado, Denver; University of California, Los Angeles; University of Utah; H. Lee Moffitt Cancer Center and Research Institute; Ochsner Health System

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: May 12, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: STU00201104